For Patients

Altace (ramipril) is an angiotensin-converting enzyme (ACE) inhibitor that reduces high blood pressure by reducing or relaxing blood vessels. Altace is used to lower blood pressure and to reduce the risk of stroke, heart attack, and increase survival in heart failure patients after a heart attack. Altace is available as a generic termed ramipril. Some common side effects of Altace are headache, cough, dizziness, malaise, and vomiting, and stomach discomfort.

Altace is available in 1.5, 2.5, 5 and 10 mg strength tablets. Serious side effects include hypotension, swelling of the face, throat or tongue, difficult breathing, jaundice, decreased urination, chest pain, fainting and flu-like symptoms. Safety and effectiveness has not been shown with Altace in the pediatric population. Altace may interact with other drugs; patients taking lithium need levels checked to prevent toxicity. When Altace is given with other drugs like diuretics or anti-inflammatory drugs, it may cause renal and potassium problems. Altace should not be used during pregnancy. Altace should not be used by pregnant
women or women who are breastfeeding due to possible fetal and neonatal harm.

Our Altace Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Dizziness, lightheadedness, or tiredness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, the adverse reaction rates observed in the clinical trials
of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice.

Hypertension

ALTACE has been evaluated for safety in over 4000
patients with hypertension; of these, 1230 patients were studied in U.S.
controlled trials, and 1107 were studied in foreign controlled trials. Almost
700 of these patients were treated for at least one year. The overall incidence
of reported adverse events was similar in ALTACE and placebo patients. The most
frequent clinical side effects (possibly or probably related to study drug)
reported by patients receiving ALTACE in placebo-controlled trials were:
headache (5.4%), dizziness (2.2%), and fatigue or asthenia (2.0%), but only the
last one was more common in ALTACE patients than in patients given placebo.
Generally the side effects were mild and transient, and there was no relation
to total dosage within the range of 1.25 mg-20 mg. Discontinuation of therapy
because of a side effect was required in approximately 3% of U.S. patients
treated with ALTACE. The most common reasons for discontinuation were: cough
(1.0%), dizziness (0.5%), and impotence (0.4%).

Of observed side effects considered possibly or probably
related to study drug that occurred in U.S. placebo-controlled trials in more
than 1% of patients treated with ALTACE, only asthenia (fatigue) was more
common on ALTACE than placebo (2% [n=13/651] vs. 1% [n=2/286], respectively).

In placebo-controlled trials, there was also an excess of
upper respiratory infection and flu syndrome in the ALTACE group, not
attributed at that time to ramipril. As these studies were carried out before
the relationship of cough to ACE inhibitors was recognized, some of these
events may represent ramipril-induced cough. In a later 1-year study, increased
cough was seen in almost 12% of ALTACE patients, with about 4% of patients
requiring discontinuation of treatment.

Reduction in the Risk of Myocardial Infarction, Stroke,
and Death from Cardiovascular Causes

HOPE Study

Safety data in the Heart Outcomes Prevention Evaluation
(HOPE) study were collected as reasons for discontinuation or temporary
interruption of treatment. The incidence of cough was similar to that seen in
the Acute Infarction Ramipril Efficacy (AIRE) trial. The rate of angioedema was
the same as in previous clinical trials [see WARNINGS AND PRECAUTIONS].

Heart Failure Post-Myocardial Infarction

AIRE Study

Adverse reactions (except laboratory abnormalities)
considered possibly/probably related to study drug that occurred in more than
1% of patients and more frequently on ALTACE are shown below. The incidences
are from the AIRE study. The follow-up time was between 6 and 46 months for
this study.

Other Adverse Reactions

Other adverse reactions reported in controlled clinical
trials (in less than 1% of ALTACE patients), or rarer events seen in post-marketing
experience, include the following (in some, a causal relationship to drug is
uncertain):

Body as a whole: Anaphylactoid reactions [see WARNINGS
AND PRECAUTIONS].

Decreases in hemoglobin or hematocrit (a low value and a
decrease of 5 g/dL or 5%, respectively) were rare, occurring in 0.4% of
patients receiving ALTACE alone and in 1.5% of patients receiving ALTACE plus a
diuretic.

Post-Marketing Experience

In addition to adverse reactions reported from clinical
trials, there have been rare reports of hypoglycemia reported during ALTACE
therapy when given to patients concomitantly taking oral hypoglycemic agents or
insulin. The causal relationship is unknown.

Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen

Increases in creatinine levels occurred in 1.2% of
patients receiving ALTACE alone, and in 1.5% of patients receiving ALTACE and a
diuretic. Increases in blood ureanitrogen levels occurred in 0.5% of patients
receiving ALTACE alone and in 3% of patients receiving ALTACE with a diuretic.
None of these increases required discontinuation of treatment. Increases in
these laboratory values are more likely to occur in patients with renal insufficiency
or those pretreated with a diuretic and, based on experience with other ACE
inhibitors, would be expected to be especially likely in patients with renal
artery stenosis [see WARNINGS AND PRECAUTIONS]. As ramipril decreases aldosterone
secretion, elevation of serum potassium can occur. Use potassium supplements
and potassium sparing diuretics with caution, and monitor the patient's serum
potassium frequently [see WARNINGS AND PRECAUTIONS].

Hemoglobin and Hematocrit

Decreases in hemoglobin or hematocrit (a low value and a
decrease of 5 g/dL or 5%, respectively) were rare, occurring in 0.4% of
patients receiving ALTACE alone and in 1.5% of patients receiving ALTACE plus a
diuretic. No US patients discontinued treatment because of decreases in
hemoglobin or hematocrit.

Other (causal relationships unknown)

Clinically important changes in standard laboratory tests
were rarely associated with ALTACE administration. Elevations of liver enzymes,
serum bilirubin, uric acid, and blood glucose have been reported, as have cases
of hyponatremia and scattered incidents of leucopenia, eosinophilia, and
proteinuria. In US trials, less than 0.2% of patients discontinued treatment
for laboratory abnormalities; all of these were cases of proteinuria or abnormal
liver-function tests.